Pipeline > APD421
Post-operative nausea & vomiting (PONV)
Description
APD421 is an intravenous formulation of a currently marketed oral drug for the new use of prevention and treatment of post-operative nausea & vomiting (PONV). The drug is a dopamine D2/D3-antagonist and data generated by Acacia Pharma suggest that it should offer significant advantages over existing dopamine antagonist anti-emetics given its therapeutic window and excellent safety profile.
Status
APD421 has been shown by Acacia Pharma to be highly effective in preclinical models of PONV. A Phase IIa clinical study to establish proof-of-concept (PoC) in cancer patients receiving the highly emetogenic chemotherapeutic agent cisplatin, demonstrated a complete response in 19 out of 23 patients (83%) when APD421 was given in combination with the 5HT3-antagonist ondansetron. Most interestingly, only 2 of the patients spontaneously reported significant nausea requiring rescue anti-emetic medication and only 2 out of 91 prospective nausea VAS measurements were above 5 on a 100 mm scale. A Phase II dose-ranging study in 223 post-surgical patients at moderate-high risk from PONV was subsequently completed in May 2012. APD421 was highly significantly superior to placebo at preventing PONV, the optimal dose approximately halving the PONV rate, from 67% in the placebo group to 36% (p=0.004). The incidence and severity of nausea were also significantly reduced. APD421 is now being prepared for Phase III.